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Global Forum for Qualified Persons for Pharmacovigilance (QPPV)

15th Anniversary


Session 6: Hot Topics in Pharmacovigilance

Session Chair(s)

Gemma  Jimenez Sese

Gemma Jimenez Sese

  • CORPORATE DRUG SAFETY HEAD - EUQPPV
  • ALMIRALL, S.A., Spain
Nicolas  Tsiakkas, MD

Nicolas Tsiakkas, MD

  • Scientific Director
  • Nicolas Tsiakkas & Co OE VAT Nr EL099974907, Greece
This will be year seven for this very popular session. Typically, the session invites speakers who are leading discussions between industry trade associations and Regulatory Authorities on the key issues of the moment. The session provides insight into what are the hot topics under discussion, what progress has been made and what are the next steps. The session is of value to participants from both large and small companies alike as there is limited attendance possible at the public meetings with EMA so this is a fantastic opportunity to hear about these topics from individuals who are directly involved. The session consists of a series of several concise presentations that cover the key messages. This session is always a crowd pleaser!

Speaker(s)

Nuria  Semis-Costa, MSc

EMA GVP on RMM: Updates from a Regulator

Nuria Semis-Costa, MSc

  • Scientific Officer
  • European Medicines Agency, Netherlands
Achint Kumar  Gupta, DrMed, MD

Signaling: EVDAS

Achint Kumar Gupta, DrMed, MD

  • EU QPPV - Safety & Benefit-Riak Management
  • Biogen, Netherlands
Judith  Weigel, MSc

EFPIA Updates: Feedback from Regulation Implementation Public Consultation

Judith Weigel, MSc

  • Pharmacist, Pharmacovigilance/ Interface Regulatory Affairs,
  • vfa - Association of Research-Based Pharmaceutical Companies, Germany
Vicki  Edwards

ICH Updates

Vicki Edwards

  • Vice President, Pharmacovigilance Excellence and International QPPV
  • AbbVie, Inc., United Kingdom